Validation of Ultrasound as a Diagnostic Tool for Assessment of Hemophilic Arthropathy of Knees and Ankles

Hemophilia Clinical Trial

Official title:

External Validation of Ultrasound as a Diagnostic Tool for Assessment of Hemophilic Arthropathy of Knees and Ankles. MRI Correlation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01232634
• Other study ID #: 1000010841
• Status: Completed
• Phase: Phase 2
• First received: October 29, 2010
• Last updated: November 8, 2016
• Start date: September 2010
• Est. completion date: March 2014

Study information

• Verified date: November 2016
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeBrazil: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to test the external validity of the systemic ultrasound protocol for data acquisition and interpretation, in order to diagnose soft tissue and osteochondral abnormalities in hemophilic children.

Description:

Ultrasound has advantages over MRI as it is less expensive, does not require sedation and is more readily available in centres around the world. Given these characteristics of ultrasound it is an ideal imaging tool for early assessment of hemophilic joints in countries whose access to MRI is limited. Early evaluation of soft tissue changes in young hemophilic patients may lead to earlier interventions and better mid-term and long-term clinical outcomes. By this way the joint function of hemophilic patients can be preserved, saving their joints from severe arthropathy and offering them the possibility of a normal professional life in the society.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 7 Years to 18 Years

Eligibility

Inclusion Criteria:

• Diagnosis of hemophilia A (factor VIII deficiency =1%) or B (factor IX deficiency =1.0%)

• Cooperative patients (age of 7 to 18 years old)

• Patients under 7 years old who have clinical evidence of arthropathy and imaging studies are required for clinical reasons. In these cases, the procedures may be done under sedation.

• Male sex (higher prevalence in males)

• History of previous ankle or knee bleed

Exclusion Criteria:

• Co-morbid illness such as juvenile idiopathic arthritis, muscular dystrophy, neuropathic arthropathy that cause osteoarticular findings that may obscure or confound the hemophilia-based joint findings

• Non-cooperative patients

• Active bleed (defined as evidence of a recent bleed with one week of the proposing imaging studies and/or musculoskeletal changes on physical examination suggestive of a bleed within one week of the proposed imaging studies).

• Prior synovectomy

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemophilia
• Hemophilia A
• Hemophilic Arthropathy
• Joint Diseases

Locations

Country	Name	City	State
Brazil	Universidade de Sao Paulo	Sao Paulo
Brazil	Universidade Estaduale de Campinas	Sao Paulo
Brazil	Universidade Federal de Sao Paulo	Sao Paulo
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Baxter Healthcare Corporation, Federal University of São Paulo, University of Campinas, Brazil, University of Sao Paulo

Countries where clinical trial is conducted

Brazil,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound findings according to the International Prophylaxis Study Group (IPSG) scale	The readers will mark all the positive findings on a standardized spreadsheet and providing a final score for each component of the scale. Color Doppler findings will be rated as normal (grade 0), mild/moderate (grade 1) or severe (grade 2) synovial hyperemia according to an atlas that shows the intensity of hyperemia, which has been prepared by our group.	Day 1	No
Secondary	MRI findings according to the International Prophylaxis Study Group (IPSG) scale	The readers will interpret the MRI findings in an additive way, i.e., marking all positive findings on a standardized spreadsheet and providing a final score for the soft tissue and osteochondral components of the MRI scale.	Day 1	No
Secondary	X-ray findings according to the Pettersson radiographic system	Each joint will be rated on a 13-point score after the Pettersson system.	Day 1	No
Secondary	Physical Assessment according to the HJHS and FISH scores	Each knee, elbow and ankle joint receives a numeric score, which can be compared to itself over time to determine whether it is showing degeneration due to bleeding. FISH score is a seven item measure of disability used to evaluate change in functional independence over time.	Day 1	No